Associate - Regulatory Affairs

Title: Associate - Regulatory Affairs

Job status: Full Time
Location: Hyderabad

Overview:
We are looking for a detail-oriented and proactive Regulatory Affairs Associate with 35 years of relevant experience in pharmaceutical Regulatory Affairs. The candidate must have hands-on experience and knowledge of regulatory requirements in major regulated markets, including those of the US FDA, European Union, and/or Health Canada.

The role will primarily support Health Canada regulatory activities, including dossier preparation, submissions, post-approval activities, regulatory responses, and coordination with cross-functional teams. The candidate will work closely with senior Regulatory Affairs team members across multiple projects.

Role & responsibilities

• Support preparation, compilation, formatting, and review of regulatory dossiers and submission documents for Health Canada.
• Compile documents and information received from different functions and ensure completeness and consistency.
• Support eCTD / dossier publishing and submission-related activities, as applicable.
• Support multiple regulatory projects and stakeholders, prioritizing activities based on project requirements and team priorities.
• Maintain regulatory trackers, submission status, commitments, approvals and related records and follow up on pending actions and deliverables.
• Support preparation of responses to regulatory queries and requests under the guidance of senior Regulatory team members.
• Assist senior team members with regulatory research and review of applicable guidelines.
• Perform other Regulatory Affairs and administrative activities as assigned.

Preferred candidate profile

• Bachelors or masters degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 3–5 years of relevant Pharmaceutical Regulatory Affairs experience.
• Hands-on USFDA regulatory experience is mandatory.
• Exposure to other regulatory markets such as Health Canada or European Union will be an advantage.
• Working knowledge of eCTD compilation and submission processes.
• Exposure with regulatory deficiency/RFI responses and post-approval change management.
• Strong working knowledge of MS Office, particularly Word and Excel.
• Strong communication, coordination, documentation, and attention-to-detail skills.
• Ability to manage multiple projects, priorities, and timelines.